Catheter navigation using impedance and magnetic field measurements

ABSTRACT

A method of operating a positioning system by registering a first coordinate system of a first positioning system in a second coordinate system of a second positioning system includes determining an interpolation function configured to register the first, non-orthonormal coordinate system in the second, orthonormal coordinate system. Fiducial pairs are collected by the respective positioning systems, each of which contain a respective coordinate in the respective coordinate system, both of which refer to the same physical point in three dimensional space. Establishing a working interpolation function involves an analysis of the fiducial pairs using a thin-plate spline algorithm. The method further includes repeatedly obtaining a first coordinate in the first coordinate system and determining a corresponding second coordinate in the second coordinate system in accordance with the interpolation function.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/231,284, filed 13 Sep. 2011.

BACKGROUND OF THE INVENTION a. Field of the Invention

The instant invention relates generally to medical device navigation andmore particularly to a system and method for registering a first medicaldevice navigation system coordinate system with a second medical devicenavigation system coordinate system.

b. Background Art

Various systems are known for determining the position and orientation(P&O) of a medical device in a human body, for example, forvisualization and navigation purposes. One such system is known as anelectrical impedance-based positioning system. Electricalimpedance-based systems generally include one or more pairs of bodysurface electrodes (e.g., patches) outside a patient's body, a referencesensor (e.g., another patch) attached to the patient's body, and one ormore sensors (e.g., electrodes) attached to the medical device. Thepairs can be adjacent, linearly arranged, or associated with respectiveaxes of a coordinate system for such a positioning system. The systemcan determine P&O by applying a current across pairs of electrodes,measuring respective voltages induced at the device electrodes (i.e.,with respect to the reference sensor), and then processing the measuredvoltages.

Another system is known as a magnetic field-based positioning system.This type of system generally includes one or more magnetic fieldgenerators attached to or placed near the patient bed or other componentof the operating environment and one or more magnetic field detectioncoils coupled with a medical device. Alternatively, the field generatorsmay be coupled with a medical device, and the detection coils may beattached to or placed near a component of the operating environment. Thegenerators provide a controlled low-strength AC magnetic field in thearea of interest (i.e., an anatomical region). The detection coilsproduce a respective signal indicative of one or more characteristics ofthe sensed field. The system then processes these signals to produce oneor more P&O readings associated with the coils (and thus with themedical device). The P&O readings are typically taken with respect tothe field generators, and thus the field generators serve as the defacto “origin” of the coordinate system of a magnetic field-basedpositioning system. Unlike an electrical impedance-based system, wherethe coordinate system is relative to the patient on which the bodysurface electrodes are applied, a magnetic field-based system has acoordinate system that is independent of the patient.

Both electrical impedance-based and magnetic field-based positioningsystems provide advantages. For example, electrical impedance-basedsystems provide the ability to simultaneously locate (i.e., provide aP&O reading for) a relatively large number of sensors on multiplemedical devices. However, because electrical impedance-based systemsemploy electrical current flow in the human body, the coordinate systemscan be non-homogenous, anisotropic, and not orthonormal (i.e., the basicvectors of the coordinate system are not guaranteed to be at rightangles to one another or to have proper unit lengths). Additionally,electrical impedance-based systems may be subject to electricalinterference. As a result, geometries and representations that arerendered based on position measurements may appear distorted relative toactual images of subject regions of interest. Magnetic field-basedcoordinate systems, on the other hand, are not dependent oncharacteristics of the patient's anatomy and provide a generallyorthonormal coordinate system. However, magnetic field-based positioningsystems are generally limited to tracking relatively fewer sensors.

There is therefore a need for a positioning system that minimizes oreliminates one or more of the challenges described above.

BRIEF SUMMARY OF THE INVENTION

It is desirable to provide a system that combines the advantages of anelectrical impedance-based positioning system (e.g., positioningmultiple sensors on multiple catheters) with the advantages of amagnetic-field based coordinate system (e.g., independence from patientanatomy, orthonormality). In an embodiment, such a system may beprovided by registering the coordinate system of an electricalimpedance-based positioning system in the coordinate system of amagnetic field-based positioning system. After registration, theelectrical impedance-based positioning system can be operated in thecoordinate system of the magnetic field-based positioning system.

A method of operating a positioning system includes a number of steps.The first step involves determining an interpolation function, which isconfigured to register a first, non-orthonormal coordinate system in asecond, orthonormal coordinate system. This first step may bepreliminary in nature (i.e., performed prior to a medical or mappingprocedure). The method further includes the steps of obtaining a firstcoordinate in the first coordinate system and determining acorresponding second coordinate in the second coordinate system inaccordance with the interpolation function. In an embodiment, thesesteps may be repeated in a real-time fashion, for example, during amedical procedure. Through the foregoing, coordinates obtained in animpedance-based positioning system, for example, may, in substantiallyreal time, be presented as corresponding coordinates in a magneticfield-based coordinate system. The resulting coordinates may be used forseveral purposes in addition to tracking devices, such as collection ofdata points on or near a tissue surface for generating a geometricalshell. Such a shell may be more accurate than a shell based oncoordinates in an electrical impedance-based coordinate system. Themethod thus relaxes the limitations on the number of sensors/devicesthat can be tracked, but includes the accuracy advantages of apatient-independent, orthonormal coordinate system.

In an embodiment, the step of determining the interpolation function mayin turn include a number of sub-steps. The first sub-step involvescollecting a plurality of fiducial pairs in three-dimensional (3D)space, each fiducial pair including (1) a first coordinate in the firstcoordinate system measured by a first positioning system and (2) asecond coordinate in the second coordinate system measured by a secondpositioning system. Each coordinate in a fiducial pair corresponds tothe same physical point in 3D space. The second sub-step involvesapplying a thin-plate spline algorithm to the plurality of fiducialpairs to yield the interpolation function.

A system for determining the position of a medical device comprises anelectronic control unit (ECU), a computer-readable memory coupled to theECU, and logic stored in the memory configured to be executed by theECU. The logic is configured to determine an interpolation function andapply the interpolation function to a first coordinate in a firstnon-orthonormal coordinate system to determine a corresponding secondcoordinate in a second orthonormal coordinate system. In an embodiment,the logic may be configured to determine the interpolation function byapplying a thin-plate spline algorithm to a plurality of fiducial pairsto yield the interpolation function. Each fiducial pair may include (1)a first coordinate in the first coordinate system measured by a firstpositioning system and (2) a second coordinate in the second coordinatesystem measured by a second positioning system. Significantly, eachcoordinate in the fiducial pair corresponds to the same physical pointin 3D space. As with the method, in an embodiment, the logic may beconfigured to determine the interpolation function during a preliminaryphase before, for example, a medical procedure. Thereafter, the logicoperates to apply the now-defined interpolation function during themedical procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram view of a system for determining the positionof a medical device by operating a first (e.g., electricalimpedance-based) medical positioning system (MPS) together with a second(e.g., magnetic field-based) MPS.

FIG. 2 is a diagrammatic and block diagram view showing, in anembodiment, an exemplary electrical impedance-based positioning systemsuitable for use in the system of FIG. 1.

FIGS. 3A-3D are schematic diagrams of exemplary dipole pairs of drivenbody surface electrodes suitable for use in the embodiment of FIG. 2.

FIG. 4 is a diagrammatic view showing, in an embodiment, an exemplarymagnetic field-based positioning system suitable for use in the systemof FIG. 1.

FIG. 5 is a schematic and block diagram view showing, in an embodiment,an exemplary magnetic field-based positioning system suitable for use inthe system of FIG. 1.

FIG. 6 is a flowchart illustrating an embodiment of a method ofoperating the positioning system of FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description includes four parts. First, a systemfor operating a first (e.g., electrical-impedance based) medicalpositioning system (MPS) together with a second (e.g., magneticfield-based) MPS will be described generally. Second, an exemplaryelectrical impedance-based MPS will be described in greater detail.Third, exemplary embodiments of a magnetic field-based MPS will bedescribed in greater detail. Finally, a method for operating a first(e.g., electrical impedance-based) MPS in the coordinate system of asecond (e.g., magnetic field-based) MPS will be described.

System for Operating a First MPS With a Second MPS. Referring now to thedrawings wherein like reference numerals are used to identify identicalcomponents in the various views, FIG. 1 is a block diagram of a system10 for determining the position of a medical device by operating a firstmedical positioning system (MPS) (e.g., electrical-impedance based)together with a second MPS (e.g., magnetic field-based). As described inthe Background, each type of positioning system has certain advantagesand disadvantages. System 10 is configured to retain the advantages ofboth systems while overcoming the respective disadvantages.

System 10 shows a first MPS 12 (electrical impedance-based) andassociated first coordinate system 14, a second MPS 16 (magneticfield-based) and associated second coordinate system 18, respectivemotion compensation blocks 20, 22, a dual-system medical device 24, asingle-system medical device 26, an electronic control unit 28(including associated processor 30 and memory 32), logic blocks and datastructures including a registration block 34, an interpolation block 36,a reference coordinate data structure 38, a computed coefficient datastructure 40, a display 42, an input/output interface 44 and an imagedatabase 46.

It should be understood that while ECU 28, MPS 12, and MPS 16 are shownseparately, this is for ease of description purposes only and is notlimiting in nature. In an embodiment, ECU 28, MPS 12, and MPS 16 may allbe implemented in a single processing apparatus or distributed amongmultiple apparatus differently than as shown. For example, MPS 12 andMPS 16 may be combined in a single MPS separate from ECU 28. In afurther embodiment, MPS 12 and MPS 16 may share components, such as ECGleads, for example. Other variations are possible, as understood bythose of ordinary skill in the art.

MPS 12 may be an electrical impedance-based positioning system and isconfigured to acquire positioning (localization) data (i.e., positionand orientation—P&O) associated with one or more electrodes attached toone or more medical devices in the body of a patient. As described ingreater detail below in connection with FIGS. 2-3, system 12 may becoupled to one or more compatible medical devices (e.g., catheter,introducer, reference device, etc.) bearing one or more electrodes.Furthermore, the system 12 typically employs a plurality of body surfaceelectrodes (i.e., patches). System 12, in an embodiment, appliesexcitation signals to patch pairs and measures resulting signals on theelectrodes (and on the patches), which measured signals are analyzed bysystem 12 to produce output P&O readings. As shown, an exemplaryposition portion of a P&O reading may be expressed in three dimensions,for example, as a 3D coordinate (nX,nY,nZ). Depending on theconfiguration, a companion set of orientation values may also bedetermined. Due to a variety of factors, the associated coordinatesystem 14 may be non-homogenous, non-orthonormal, and anisotropic.

MPS 16 may be a magnetic field-based positioning system and is likewiseconfigured to acquire positioning (localization) data (i.e., positionand orientation—P&O) associated with one or more sensors attached orotherwise associated with one or more medical devices in the body of thepatient. As described in greater detail below in connection with FIG. 5,MPS 16 may be coupled to one or more compatible medical devices bearingone or more sensors (e.g., field sensors, such as coils), and further,typically includes a plurality of electromagnetic field generators. MPS16 controls both the electromagnetic field generation, as well as thedetection of signals at each of the sensors, which detected signals areindicative of one or more field characteristics of the sensed fields.MPS 16 is configured to process the detected signals and output P&Oreadings. As shown, an exemplary position portion of a P&O reading maybe expressed in three dimensions, for example, as a 3D coordinate(gX,gY,gZ). Depending on the configuration, a companion set oforientation values may also be determined. In general, the associatedcoordinate system 18 is homogeneous and orthonormal. However, asdescribed in the Background, MPS 16 may be limited in the number ofsensors for which P&O can be determined at one time.

It should be understood that coordinate systems 14, 18 may beindependent of each other, with separate orientations and differentorigins, and may be movable relative to each other. In addition, incertain embodiments, motion compensation functionality may be providedby either or both of MPS 12 and MPS 16. In the illustrative embodiment,both positioning systems include such functionality, shown by motioncompensation blocks 20, 22. Motion compensation functionality providedby blocks 20, 22 may be independent of each other. Generally, motioncompensation blocks may allow for adjustment of raw position dataobtained by MPS 12 and MPS 16, respectively, to account for movement ofa patient body region of interest (ROI) relative to a pre-acquiredimage, series of images, or geometry of the ROI. Motion compensation foran electrical impedance-based positioning system will be described ingreater detail in conjunction with FIG. 2. Motion compensation for amagnetic field-based positioning system will be described in greaterdetail in conjunction with FIG. 5. Motion compensation may also beprovided for physiological (e.g., respiratory) activity, and/or may begated for a particular point, e.g., a point in time in a cardiac cycle.

Dual-system medical device 24 is configured to be compatible with bothMPS 12 and MPS 16 (i.e., is configured to cooperate with respectiveexcitation and sensing schemes for both systems for determiningposition). As shown, device 24 is operatively coupled to each one of MPS12 and MPS 16. Device 24 is particularly configured to aid registrationof coordinate systems 14, 18. For this purpose, device 24 is providedwith at least one “sensor-pair”, where one sensor of the pair iscompatible with and operatively coupled to MPS 12 while the other sensorof the pair is compatible with and operatively coupled to MPS 16. Bothsensors in each sensor-pair are configured to output a respective signalto the corresponding positioning system. Such signals are thereafterused by respective systems 12, 16 to determine a respective position andorientation (P&O), expressed in its associated coordinate system. Moreparticularly, sensors in a sensor-pair may at least be at a knowndistance or relationship from each other, and preferably be in suchproximity to each other as to be considered to practically occupy thesame physical point in three-dimensional space. As described below,respective P&O readings for each sensor of a sensor-pair are referred toherein as a fiducial pair. The recognition that each coordinate of afiducial pair in reality refers to the same physical point in 3D spacepermits certain equivalences to be used in a preliminary registration ofsystem 10 (described below in greater detail). Dual-system device 24comprises at least one sensor-pair, and may have multiple sensor-pairs.It should be understood that device 24 may include additional electrodesand/or sensors. In particular, it can be advantageous for device 24 toinclude either two sensor pairs or a second sensor for at least one ofthe MPS systems 12, 16. In an embodiment in which two sensors in asensor-pair are not at the same physical point in device 24, the secondsensor pair or additional sensor can be used to properly orient thedevice for calculating the location of the fiducial pairs. Device 24 maybe an electrophysiology (EP) mapping catheter, another EP catheter, orother diagnostic or treatment device.

Single-system medical device 26 is configured to be compatible with MPS12, and, as shown, is operatively coupled to MPS 12. In this regard,device 26 includes one or more electrodes capable of sensing anelectrical characteristic, which, when processed by MPS 12, outputs aP&O reading, expressed relative to coordinate system 14. In anembodiment, device 26 is configured for use in a medical procedure,mapping procedure, or other activity following the initial registrationof coordinate systems 14, 18. In an embodiment, the initial registration(described below) may be valid for the duration of a particular medicalsession. Device 26 may be one of a plurality of medical device types,such as a non-contact EP mapping catheter that includes a plurality ofelectrodes. Device 26 may also be an ablation catheter, other EPcatheter, or other diagnostic or treatment device.

Display 42 is configured to produce one or more images of interest suchas, for example, anatomical images relating to a region of interest.Display 42 may comprise conventional apparatus known in the art.

Input/output mechanisms 44 are provided as an interface that allows auser (not shown) to interact with system 10, including variouscomponents of system 10, such as ECU 28. Input/output 44 may compriseconventional apparatus known in the art.

Image database 46 is configured to store image information relating tothe patient's body, including, for example, a moving region of interest.Image database 46 may include (1) one or more two-dimensional stillimages acquired at respective, individual times in the past; (2) aplurality of related two-dimensional images obtained in real-time froman image acquisition device (e.g., fluoroscopic images from an x-rayimaging apparatus) wherein the image database acts as a buffer (“live”fluoroscopy); and/or (3) a sequence of related two-dimensional imagesdefining a cine-loop (CL) wherein each image in the sequence has atleast an ECG timing parameter associated therewith adequate to allowplayback of the sequence in accordance with acquired real-time ECGsignals obtained from an ECG monitor (not shown in FIG. 1). It should beunderstood that the two-dimensional images may be acquired through anyimaging modality, now known or hereafter developed, for example X-ray,ultrasound, computerized tomography, nuclear magnetic resonance or thelike.

ECU 28 is configured to perform a number of functions, as described ingreater detail below. First, ECU 28 is responsive to at least positiondata from MPS 12 and MPS 16 (i.e., fiducial pairs) to determine aninterpolation function that allows registration of coordinate system 14to coordinate system 18 (“registration”). Second, ECU 28 is furtherconfigured to take a coordinate in coordinate system 14 (generated byMPS 12) and, using the interpolation function, output a correspondingcoordinate in coordinate system 18 (“interpolation”). While ECU 28 maybe also configured generally to perform other useful functions known inthe art (e.g., process position data, interpret user input, generatedisplay data, accurately superimpose a representation of the medicaldevice on a pre-acquired image or sequence of images obtained from imagedatabase 46, etc.), the following description will focus on the twofunctions stated above, namely, registration and interpolation. Toperform these functions, ECU 28 is particularly configured to includeregistration logic 34 and interpolation logic 36, each of which in anembodiment takes the form of programmed logic (i.e., software) stored inmemory 32 and configured to be executed by processor 30. ECU 28 alsoincludes various data structures, including reference coordinate datastructure 38 and coefficient data structure 40.

Registration logic 34 is configured to establish an interpolationfunction to register a first, non-orthonormal coordinate system (e.g.,coordinate system 14) in a second, orthonormal coordinate system (e.g.,coordinate system 18). To do so, registration logic 34 may be configuredto receive a set of fiducial pairs. Each fiducial pair may include acoordinate in each coordinate system, both coordinates representing thesame physical point in three-dimensional (3D) space, or two points in 3Dspace in a predetermined, known relationship with each other (e.g.,distance). The set of fiducial pairs, then, may be an N-sized set ofpaired respective coordinates in coordinate systems 14, 18. N may beselected as an arbitrary number of fiducial pairs large enough (anddiverse enough across the region of interest) to map a relevant portionof the coordinate systems, such as a patient ROI, for example. Fiducialpair coordinates in coordinate system 14, shown as(nX_(i),nY_(i),nZ_(i)), i=1, . . . , N, may be received from MPS 12.Fiducial pair coordinates in coordinate system 18, shown as(gX_(i),gY_(i),gZ_(i)), i=1, . . . , N, may be received from MPS 16. Asused herein, the prefix n refers to electrical impedance-based systemsand coordinates, and the prefix g refers to magnetic field-based systemsand coordinates.

Based on the received fiducial pairs, registration logic 34 may processand/or store a set of reference coordinates in data structure 38. In anembodiment, the reference coordinates stored in structure 38 are theN-sized set of n-coordinates received from MPS 12. Registration logic 34may also be configured to define an interpolation function using aninterpolation algorithm. In an embodiment, the algorithm is a thin-platespline algorithm, which will be discussed in greater detail inconjunction with FIG. 5. Registration logic 34 is further configured tocalculate coefficients 40, which are used in defining the interpolationfunction. The output of registration logic 34 may define a map ofcoordinate system 14 onto coordinate system 18. The output may be in theform of an established interpolation function, including coefficients 40and reference coordinates 38. Alternatively, the output may be in theform of coefficients 40 and reference coordinates 38, to be used with apre-programmed interpolation function.

Interpolation logic 36 is configured to follow the map created byregistration logic 34, i.e., to apply the interpolation function to anew n-coordinate (impedance-based) in coordinate system 14 (shown as(nX,nY,nZ)) to yield a corresponding g-coordinate (shown as (gX,gY,gZ)).This data flow is shown in FIG. 1. In an embodiment, it is contemplatedthat logic 36 will process a real time stream of new n-coordinates toproduce a corresponding real time stream of g-coordinates. Generally,interpolation logic 36 is configured (1) to apply a pre-programmedinterpolation function, which makes use of reference coordinates 38 andcoefficients 40, or (2) to apply an interpolation function establishedentirely by registration logic 34. In an embodiment, the interpolationfunction may be based on the same thin-plate spline algorithm applied byregistration logic 34, recognizing that unknowns such as coefficientswill be defined when interpolation logic 36 uses the algorithm.

In operation, system 10 may be used to register coordinate system 14 incoordinate system 18 in a preliminary, registration phase of an EP orother medical procedure. As noted above, the registration step may bebased on an assessment of a plurality of measured fiducial pairs, andthe equivalence that the same physical point represents in therespective coordinate systems 14, 18. MPS 12 and MPS 16 are configuredto collect fiducial pairs using dual-system device 24. In this regard,ECU 28 may be configured to synchronize and/or control the collection ofposition data from each of MPS 12 and MPS 16. Thereafter, the collectedfiducial pairs are provided to registration logic 34, which applies aninterpolation algorithm. While described in much greater detail below,the interpolation algorithm involves defining a plurality of equationswith a plurality of unknowns, and then solving for the unknowns. Thecollected fiducial pairs provide some of the information involved insolving for the unknowns. Various terms specified in the equationsinclude corresponding coefficients, and the values determined for thesecoefficients (i.e., in solving the set of equations) are reflected inthe data structure 40. The collected fiducial pairs also may comprise aset of reference coordinates, reflected in data structure 38. In anembodiment, this completes the registration phase.

In real-time—i.e., during a treatment or other phase following theregistration phase—interpolation logic 36 may continuously acceptcoordinates from MPS 12. The coordinates may be derived fromsingle-system device 26, dual-system device 24, or another medicaldevice compatible with MPS 12 (electrical impedance-based). As describedabove, interpolation logic 36 is configured to apply the interpolationfunction (which uses reference coordinates 38 and coefficients 40) toeach received coordinate in coordinate system 14 and output acorresponding coordinate in coordinate system 18. As a result, system 10may effectively operate MPS 12 in coordinate system 18 in real-time.System 10 thus takes advantage of the ability of MPS 12 to determine theposition of multiple electrodes on multiple devices simultaneously andat the same time benefits from the orthonormality andpatient-independence of coordinate system 18. For example, position datacollected in coordinate system 14 for purposes of generating ageometrical model or surface map of anatomical features will be shownwith improved correspondence to actual images of the same anatomicalfeatures (i.e., without distortion). During real-time operation, MPS 16may be removed from system 10, disabled, or not used, or may continue tobe used to acquire position data.

Electrical Impedance-Based MPS. FIG. 2 is a diagrammatic overview of anexemplary electrical impedance-based embodiment of MPS 12, designatedsystem 50 (i.e., which can be used in system 10—FIG. 1). System 50 maycomprise various visualization, mapping and navigation components asknown in the art, including, for example, an EnSite™ Electro AnatomicalMapping System commercially available from St. Jude Medical, Inc., or asseen generally by reference to U.S. Pat. No. 7,263,397 entitled “Methodand Apparatus for Catheter Navigation and Location and Mapping in theHeart” to Hauck et al., or U.S. Patent Publication No. 2007/0060833 A1to Hauck entitled “Method of Scaling Navigation Signals to Account forImpedance Drift in Tissue”, both owned by the common assignee of thepresent invention, and both hereby incorporated by reference in theirentireties.

System 50 includes a diagrammatic depiction of a heart 52 of a patient54. The system includes the ability to determine a catheter electrodelocation (i.e., position and orientation) as the catheter distal end ismoved around and within a chamber of the heart 52. For this purpose,three sets of body surface electrodes (patches) are shown: (1)electrodes 56, 58 (X-axis); (2) electrodes 60, 62 (Y-axis); and (3)electrodes 64, 66 (Z-axis). Additionally, a body surface electrode(“belly patch”) 68 is shown diagrammatically. The surface electrodes areall connected to a switch 70. Of course, other surface electrodeconfigurations and combinations are suitable for use with the presentinvention, including fewer electrodes, e.g., three electrodes, moreelectrodes, e.g., twelve, or different physical arrangements, e.g.,linear arrangement instead of an orthogonal arrangement.

Device 26 is also shown as a catheter with a distal electrode 72.Catheter 26 may have additional electrodes in addition to electrode 72(e.g., a catheter tip electrode and/or ring electrodes). FIG. 2 alsoshows a second, independent catheter 74 with a fixed reference electrode76, which may be stationary on the heart for calibration purposes. Inmany instances, a coronary sinus electrode or other fixed referenceelectrode 76 in the heart 52 can be used as a reference for measuringvoltages and displacements.

It should be understood that catheter 26 may include still otherelectrodes, and in other embodiments, such as in EP or RF ablationembodiments, the other electrodes may be used for any number ofdiagnostic and/or therapeutic purposes. For instance, such electrodesand therefore such catheters may be used for performing ablationprocedures, cardiac mapping, electrophysiological (EP) studies and otherdiagnostic and/or therapeutic procedures. Embodiments are not limited toany one type of catheter or catheter-based system or procedure.

FIG. 2 further shows a computer system 78, a signal generator 80, ananalog-to-digital converter 82 and a low-pass filter 84. Computer system78 includes a processing apparatus configured to perform many of thefunctions and operations described herein. Computer system 78 may beconfigured to control signal generator 80 in accordance withpredetermined strategies to selectively energize various pairs (dipoles)of surface electrodes, as described in greater detail below. Inoperation, computer system 78 may (1) obtain raw patch data (i.e.,voltage readings) via filter 84 and A-to-D converter 82 and (2) use theraw patch data (in conjunction with electrode measurements) to determinethe raw, uncompensated, electrode location coordinates of a catheterelectrode positioned inside the heart or chamber thereof (e.g., such aselectrode 72) in three-dimensional coordinate system 14. Computer system78 may be further configured to perform one or more compensation andadjustment functions, and to output a location in coordinate system 14of one or more electrodes such as electrode 72. Motion compensation mayinclude, for example, compensation for respiration-induced patient bodymovement, as described in U.S. patent application Ser. No. 12/980,515,entitled “Dynamic Adaptive Respiration Compensation With Automatic GainControl”, which is hereby incorporated by reference in its entirety.

In an embodiment, most or all of the conventional twelve (12) ECG leads,coupled to body surface electrodes and designated collectively byreference numeral 86, may be provided to support the acquisition of anelectro-cardiogram (ECG) of the patient 54. As shown, ECG leads 86 (ifprovided) may be coupled directly to computer system 78 for acquisitionand subsequent processing to obtain the phase of the heart in thecardiac cycle. ECG leads 86 may be also be provided to other systems.

Each body surface (patch) electrode is independently coupled to switch70 and pairs of electrodes are selected by software running on computersystem 78, which couples the patches to signal generator 80. A pair ofelectrodes, for example the Z-axis electrodes 64 and 66, may be excitedby signal generator 80 to generate an electrical field in the body ofpatient 54 and heart 52. In one embodiment, this electrode excitationprocess occurs rapidly and sequentially as different sets of patchelectrodes are selected and one or more of the unexcited (in anembodiment) surface electrodes are used to measure voltages. During thedelivery of the excitation signal (e.g., current pulse), the remaining(unexcited) patch electrodes may be referenced to the belly patch 68 andthe voltages impressed on these remaining electrodes are measured by theA-to-D converter 82. In this fashion, the surface patch electrodes aredivided into driven and non-driven electrode sets. Low pass filter 84may process the voltage measurements. The filtered voltage measurementsare transformed to digital data by analog to digital converter 82 andtransmitted to computer 78 for storage under the direction of software.This collection of voltage measurements is referred to herein as the“patch data.” The software has access to each individual voltagemeasurement made at each surface electrode during each excitation ofeach pair of surface electrodes.

The patch data is used, along with measurements made at electrode 72, todetermine a relative location of electrode 72 in coordinate system 14.Potentials across each of the six orthogonal surface electrodes may beacquired for all samples except when a particular surface electrode pairis driven (in an embodiment). In one embodiment, sampling while asurface electrode acts as a source or sink in a driven pair is normallyavoided as the potential measured at a driven electrode during this timemay be skewed by the electrode impedance and the effects of high localcurrent density. In an alternate embodiment, however, sampling may occurat all patches (even those being driven).

Generally, in one embodiment, three nominally orthogonal electric fieldsare generated by a series of driven and sensed electric dipoles in orderto realize localization function of the catheter in a biologicalconductor. Alternately, these orthogonal fields can be decomposed andany pair of surface electrodes (e.g., non-orthogonal) may be driven asdipoles to provide effective electrode triangulation.

FIGS. 3A-3D show a plurality of exemplary non-orthogonal dipoles,designated D₀, D₁, D₂ and D₃, set in coordinate system 14. In FIGS.3A-3D, the X-axis surface electrodes are designated X_(A) and X_(B), theY-axis surface electrodes are designated Y_(A) and Y_(B), and the Z-axiselectrodes are designated Z_(A) and Z_(B). For any desired axis, thepotentials measured across an intra-cardiac electrode 72 resulting froma predetermined set of drive (source-sink) configurations may becombined algebraically to yield the same effective potential as would beobtained by simply driving a uniform current along the orthogonal axes.Any two of the surface electrodes 56, 58, 60, 62, 64, 66 (see FIG. 2)may be selected as a dipole source and drain with respect to a groundreference, e.g., belly patch 68, while the unexcited body surfaceelectrodes measure voltage with respect to the ground reference. Themeasurement electrode 72 placed in heart 52 is also exposed to the fieldfrom a current pulse and is measured with respect to ground, e.g., bellypatch 68. In practice, a catheter or multiple catheters within the heartmay contain multiple electrodes and each electrode potential may bemeasured separately. As previously noted, alternatively, at least oneelectrode may be fixed to the interior surface of the heart to form afixed reference electrode 76, which may also be measured with respect toground.

Data sets from each of the surface electrodes and the internalelectrodes are all used to determine the location of measurementelectrode 72 within heart 52. After the voltage measurements are made, adifferent pair of surface electrodes is excited by the current sourceand the voltage measurement process of the remaining patch electrodesand internal electrodes takes place. The sequence occurs rapidly, e.g.,on the order of 100 times per second in an embodiment. To a firstapproximation the voltage on the electrodes within the heart bears alinear relationship with position between the patch electrodes thatestablish the field within the heart, as more fully described in U.S.Pat. No. 7,263,397 referred to above.

In summary, FIG. 2 shows an exemplary system that employs seven bodysurface electrodes (patches), which may be used for injecting currentand sensing resultant voltages. Current may be driven between twopatches at any time. Measurements may be performed between a non-drivenpatch and, for example, belly patch 68 as a ground reference. A patchbio-impedance, also referred to as a “patch impedance” may be computedaccording to the following equation:

${Bio{{Z\left\lbrack n\rightarrow m \right\rbrack}\lbrack k\rbrack}} = \frac{V_{k}}{I_{n\rightarrow m}}$

where V_(k) is the voltage measured on patch k and I_(n→m) is a knownconstant current driven between patches n and m. The position of anelectrode may be determined by driving current between different sets ofpatches and measuring one or more patch impedances. In one embodiment,time division multiplexing may be used to drive and measure allquantities of interest. Position determining procedures are described inmore detail in U.S. Pat. No. 7,263,397 and Publication 2007/0060833referred to above, as well as other references.

As stated in the Background, because electrical impedance-based systemsdepend on electrical current flow in the human body, their coordinatesystems (i.e., the electrical fields produced in the human body) can benon-homogenous, anisotropic, and not orthonormal. System 50 may includefeatures to account for such electrical field inconsistencies, such ascorrection of inhomogenous electrical fields, as described in U.S.Patent Application Publication 2008/0221643, entitled “System and Methodfor Correction of Inhomogenous Fields”, which is hereby incorporated byreference in its entirety.

Magnetic Field-Based MPS. FIG. 4 is a diagrammatic view of an exemplarymagnetic field-based embodiment of MPS 16 in a fluoroscopy-based imagingenvironment, designated system 88. The system 88 includes a magnetictransmitter assembly (MTA) 90 and a magnetic processing core 92 fordetermining position and orientation (P&O) readings. The MTA 90 isconfigured to generate the magnetic field(s) in and around the patient'schest cavity in a predefined three-dimensional space designated asmotion box 94 in FIG. 4. Magnetic field sensors coupled with dual-systemdevice 24 or another medical device are configured to sense one or morecharacteristics of the magnetic field(s) and, when the sensors are inthe motion box 94, each generates a respective signal that is providedto the magnetic processing core 92. The processing core 92 is responsiveto these detected signals and is configured to calculate respectivethree-dimensional position and orientation (P&O) readings for eachmagnetic field sensor in the motion box 94. Thus, the MPS system 88enables real-time tracking of each magnetic field sensor inthree-dimensional space. The position of the sensors may be shown on adisplay 96 relative to, for example only, a cardiac model or geometry.

FIG. 5 is a schematic and block diagram view of another exemplarymagnetic field-based embodiment of MPS 16, designated MPS 110, as alsoseen by reference to U.S. Pat. No. 7,386,339, hereby incorporated byreference in its entirety, and portions of which are reproduced below.It should be understood that variations are possible, for example, asalso seen by reference to U.S. Pat. Nos. 7,197,354, and 6,233,476, alsohereby incorporated by reference in their entireties.

MPS system 110 includes a location and orientation processor 150, atransmitter interface 152, a plurality of look-up table units 154 ₁, 154₂ and 154 ₃, a plurality of digital to analog converters (DAC) 156 ₁,156 ₂ and 156 ₃, an amplifier 158, a transmitter 160, a plurality of MPSsensors 162 ₁, 162 ₂, 162 ₃ and 162 _(N), a plurality of analog todigital converters (ADC) 164 ₁, 164 ₂, 164 ₃ and 164 _(N) and a sensorinterface 166.

MPS 110 is configured to acquire positioning (localization) data (i.e.,position and orientation—P&O) of MPS sensors 162. For some sensors 162,the P&O may be expressed with five degrees of freedom as a position(i.e., a coordinate in three axes X, Y and Z) and orientation (i.e., anazimuth and elevation) of the respective sensor 162 in a magnetic fieldrelative to magnetic field transmitter 160. For other sensors 162, theP&O may be expressed with six degrees of freedom as a position (X, Y,and Z) and orientation (i.e., roll, pitch, and yaw). The P&O may bebased on capturing and processing the signals received from a sensor 162while in the presence of a controlled low-strength AC magnetic field.Accordingly, sensors 162 may each comprise one or more magnetic fielddetection coil(s), and it should be understood that variations as to thenumber of coils, their geometries, spatial relationships, the existenceor absence of cores and the like are possible. From an electromagneticperspective, all sensors are created equal: voltage is induced on a coilresiding in a changing magnetic field, as contemplated here. Sensors 162are thus configured to detect one or more characteristics of themagnetic field(s) in which they are disposed and generate an indicativesignal, which is further processed to obtain the P&O thereof. For oneexample of a sensor, see U.S. Pat. No. 7,197,354 entitled “System forDetermining the Position and Orientation of a Catheter” issued to Sobe,hereby incorporated by reference in its entirety.

Transmitter interface 152, DAC units 156, and transmitter 160 areprovided to create the controlled low-strength AC magnetic field. MPSsensors 162, ADC units 164, and sensor interface 166 are provided tocreate signals indicative of characteristics of the field for P&Odetermination. Transmitter interface 152 is connected to location andorientation processor 150 and to look-up table units 154 ₁, 154 ₂ and154 ₃. DAC units 156 ₁, 156 ₂ and 156 ₃ are connected to a respectiveone of look-up table units 154 ₁, 154 ₂ and 154 ₃ and to amplifier 158.Amplifier 158 is further connected to transmitter 160. Transmitter 160,also marked TX, may be coupled to a portion of the operating environment(e.g., bed or an imaging apparatus). MPS sensors 162 ₁, 162 ₂, 162 ₃ and162 _(N) are further marked RX₁, RX₂, RX₃ and RX_(N), respectively.Analog to digital converters (ADC) 164 ₁, 164 ₂, 164 ₃ and 164 _(N) arerespectively connected to sensors 162 ₁, 162 ₂, 162 ₃ and 162 _(N) andto sensor interface 166. Sensor interface 166 is further connected tolocation and orientation processor 150.

Each of look-up table units 154 ₁, 154 ₂ and 154 ₃ produces a cyclicsequence of numbers and provides it to the respective DAC unit 156 ₁,156 ₂ and 156 ₃, which in turn translates it to a respective analogsignal. Each of the analog signals is respective of a different spatialaxis. In the present example, look-up table 154 ₁ and DAC unit 156 ₁produce a signal for the X axis, look-up table 154 ₂ and DAC unit 156 ₂produce a signal for the Y axis and look-up table 154 ₃ and DAC unit 156₃ produce a signal for the Z axis.

DAC units 156 ₁, 156 ₂ and 156 ₃ provide their respective analog signalsto amplifier 158, which amplifies and provides the amplified signals totransmitter 160. Transmitter 160 provides a multiple axiselectromagnetic field, which can be detected by MPS sensors 162 ₁, 162₂, 162 ₃ and 162 _(N). Each of MPS sensors 162 ₁, 162 ₂, 162 ₃ and 162_(N) detects an electromagnetic field, produces a respective electricalanalog signal and provides it to the respective ADC unit 164 ₁, 164 ₂,164 ₃ and 164 _(N) connected thereto. Each of the ADC units 164 ₁, 164₂, 164 ₃ and 164 _(N) digitizes the analog signal fed thereto, convertsit to a sequence of numbers and provides it to sensor interface 166,which in turn provides it to location and orientation processor 150.Location and orientation processor 150 analyzes the received sequencesof numbers, thereby determining the location and orientation of each ofthe MPS sensors 162 ₁, 162 ₂, 162 ₃ and 162 _(N). Location andorientation processor 150 further determines distortion events andupdates look-up tables 154 ₁, 154 ₂ and 154 ₃, accordingly. In anembodiment in which MPS 110 is implemented as a part of system 10 (e.g.,as MPS 16), location and orientation processor 150 may be implemented asa part of ECU 28.

MPS 110 may compensate for respiration-induced and other patient bodymotion, substantially as described in U.S. patent application Ser. No.12/650,932, entitled “Compensation of Motion in a Moving Organ Using anInternal Position Reference Sensor”, hereby incorporated by reference inits entirety. One of MPS sensors 162 may be a patient reference sensor(PRS) configured to provide a stable positional reference on thepatient's body for such motion compensation. The PRS may be attached tothe patient's manubrium sternum or another location.

In an embodiment, MPS 110 may also include an electro-cardiogram (ECG)monitor (not shown in FIG. 5) configured to continuously detect anelectrical timing signal of the heart organ through the use of aplurality of ECG electrodes (not shown), which may be externally-affixedto the outside of a patient's body. The timing signal generallycorresponds to the particular phase of the cardiac cycle, among otherthings. The ECG signal may be used for ECG synchronized play-back of apreviously captured sequences of images (cine loop). The ECG monitor andECG-electrodes may comprise conventional components.

Combined System 10. FIG. 6 is a flowchart of a method of operating apositioning system, designated method 200. Method 200 will be describedwith reference to an embodiment of system 10. In the followingembodiment, MPS 12 is an electrical impedance-based positioning system,and MPS 16 is a magnetic field-based positioning system. However, itshould be understood that the method described herein may find use withother systems, other MPS types, and other combinations thereof.Consistent with previous portions of this disclosure, descriptions andcoordinate symbols beginning with n are associated with an electricalimpedance-based positioning system, whereas descriptions and coordinatesymbols beginning with g are associated with a magnetic field-basedpositioning system.

Method 200 begins at step 202 by determining an interpolation functionconfigured to register coordinate system 14 associated with MPS 12 in asecond coordinate system 18 associated with second MPS 16. Step 202includes two sub-steps 204, 206. The first sub-step 204 involvescollecting a plurality of fiducial pairs in three-dimensional (3D) spacethroughout the physical 3D space (i.e., the region of interest,typically in an anatomical regional of interest in a patient). It shouldbe understood that both coordinate systems 14, 18 are defined throughoutthis physical 3D space. Accordingly, each fiducial pair will include (1)a first coordinate expressed in coordinate system 14 (measured by MPS12), represented by (nX,nY,nZ), and (2) a second coordinate expressed incoordinate system 18 (measured by MPS 16), represented by (gX,gY,gZ).Fiducial pairs may be collected using a single device (e.g., device 24)compatible with both MPS 12 and MPS 16. Collection may be performedunder the direction of ECU 28. The collected fiducial pairs may coverthe entire navigational domain (i.e., volume or region of interest).Coordinates in a fiducial pair may be respectively and independentlycompensated for patient body motion by MPS 12 and MPS 16 as describedhereinabove. To ensure a smooth interpolation function, sub-step 204 mayalso involve discarding fiducial pairs whose coordinates correspond to aphysical point that is less than a pre-determined minimum distance(e.g., 4 millimeters) from another physical point corresponding to apreviously-collected fiducial pair. Degenerate pairs (i.e., twodifferent n-coordinates for a single g-coordinate, or vice-versa) mayalso be discarded. For the interpolation function to be unambiguous,collected fiducial pairs must not all lie in the same plane (i.e., thefiducial pairs must represent physical points in the region of interestthat span all three dimensions).

Second sub-step 206 involves applying an interpolation algorithm to thecollected plurality of fiducial pairs to yield a defined interpolationfunction. Sub-step 206 can also be considered a registration step inwhich the n coordinate system 14 is registered in the g coordinatesystem 18. In an embodiment, the interpolation algorithm used is thethin plate spline algorithm (“the algorithm”), but other interpolationalgorithms may find use with method 200 and system 10. The followingdescription of the thin plate spline algorithm uses basis function r,though other basis functions may be used and remain within the scope andspirit of the present invention. Furthermore, the algorithm as describedherein is directed to the registration of an inhomogenous,non-orthonormal electrical impedance-based coordinate system with agenerally orthonormal magnetic field-based coordinate system, but othercoordinate system type registrations may be performed with the algorithmand/or with method 200.

ECU 28 (e.g., via registration logic 34) is configured to perform theprocessing functions in sub-steps 204, 206.

The algorithm accepts the fiducial pairs collected in sub-step 204 as aninput, wherein each fiducial pair has the following two coordinates:

(nX_(i),nY_(i),nZ_(i))

and

(gX_(i),gY_(i),gZ_(i))

Where the subscript index i=1, . . . , N is the index numbering thefiducial pairs and N is the total number of non-discarded fiducial pairscollected in sub-step 204. In an embodiment, about 200 fiducial pairsmay well describe a geometry and also allow a defined interpolationfunction to operate robustly in real time, so N may be about 200.Variation to the number of fiducial pairs is possible, as will beappreciated by those of ordinary skill in the art.

The goal of the interpolation algorithm is to compute a continuous maprelating the entire n-coordinate system 14 to the entire g-coordinatesystem 18. In the thin plate spline algorithm, the map can berepresented by a function in each dimension that relates a point(nX,nY,nZ) in n-space to a point (gX,gY,gZ) in g-space as set forth inthe set of equations (1) below:

$\begin{matrix}{{{{g{X\left( {{nX},{nY},{nZ}} \right)}} = {{b_{1}^{x}nX} + {b_{2}^{x}{nY}} + {b_{3}^{x}nZ} + c^{x} + {\sum\limits_{j = 1}^{N}{a_{j}^{x}{\Psi_{j}\left( {n\; } \right)}}}}}{{gY}\left( {{nX},{nY},{nZ}} \right)} = {{b_{1}^{y}nX} + {b_{2}^{y}{nY}} + {b_{3}^{y}nZ} + c^{y} + {\sum\limits_{j = 1}^{N}{a_{j}^{y}{\Psi_{j}\left( {n} \right)}}}}}{{g{Z\left( {{nX},{nY},{nZ}} \right)}} = {{b_{1}^{z}nX} + {b_{2}^{z}{nY}} + {b_{3}^{z}{nZ}} + c^{z} + {\sum\limits_{j = 1}^{N}{a_{j}^{z}{\Psi_{j}\left( {n} \right)}}}}}} & (1)\end{matrix}$

where a_(j) ^(x), a_(j) ^(y), a_(j) ^(z), b_(k) ^(x), b_(k) ^(y), b_(k)^(z), and c^(x), c^(y), c^(z), j=1, . . . , N, k=1, 2, 3, are(initially-unknown) coefficients (e.g., coefficients 40) for whichrespective values must be determined, n

is the three-dimensional point (nX,nY,nZ), and Ψ_(j)(n

) is a three-dimensional basis function. The basis function may beselected from a range of the radial basis functions. The exact form ofthe basis function may be defined according to the dimensionality of thespline (the spline is three-dimensional for the algorithm describedherein). One set of radial basis functions that may be used is theEuclidean distance as set forth in equation (2) below:

Ψ_(j)(n

)=√{square root over ((nX−x _(j))²+(nY−y _(j))²+(nZ−z _(j))²)}  (2)

which may be expressed in short form as in equation (3) below:

Ψ_(j)(n

)=|n

−n

|  (3)

Solving for the unknown coefficients may include a smoothing parameterλ, which controls how close the mapped solution g(nX_(i),nY_(i),nZ_(i))is to the measured point (gX_(i),gY_(i),gZ_(i)). In other words,smoothing parameter λ determines the amount by which a g-coordinateoutput by the interpolation function based on an particular n-coordinateinput can differ from a measured g-coordinate in a fiducial pair withthe particular n-coordinate. If λ is set to zero, the mapped solution(i.e., interpolation function output) for each measured n-coordinate isequal to the measured g-coordinate in a fiducial pair with thatn-coordinate, such that g(nX_(i),nY_(i),nZ_(i))=(gX_(i),gY_(i),gZ_(i))for all (nX_(i),nY_(i)nZ_(i)). A non-zero λ results in a smoothersolution by avoiding over-fitting noisy measurements in the fiducialpairs. The value of λ, may vary from registration to registration and/orfrom system to system. In general, λ may be a number greater than zerodetermined through routine experimentation to strike a proper balancebetween accurately reflecting measured fiducial pairs and avoidingover-fitting noisy measurements. λ may have a value relative to thenumber of fiducial pairs. For example, in an embodiment, λ may beassigned the value 0.025N, where N is the number of fiducial pairs(e.g., such that λ=5 for N=200). Implementing λ and setting equations(1) in an iterative form to solve for the 3N+12 coefficients results inthe following set of equations (4):

$\begin{matrix}{{{gX}_{i} = {{b_{1}^{x}{nX}_{i}} + {b_{2}^{x}{nY}_{i}} + {b_{3}^{x}{nZ}_{i}} + c^{x} + {\sum\limits_{j = 1}^{N}{a_{j}^{x}\left( {{\Psi_{j}\left( {n\; } \right)} - {\lambda \; \delta_{ij}}} \right)}}}}{{gY}_{i} = {{b_{1}^{y}{nX}_{i}} + {b_{2}^{y}{nY}_{i}} + {b_{3}^{y}{nZ}_{i}} + c^{y} + {\sum\limits_{j = 1}^{N}{a_{j}^{y}\left( {{\Psi_{j}\left( {n\; } \right)} - {\lambda \; \delta_{ij}}} \right)}}}}} & (4)\end{matrix}$

$\begin{matrix}{{{gZ}_{i} = {{b_{1}^{z}{nX}_{i}} + {b_{2}^{z}{nY}_{i}} + {b_{3}^{z}{nZ}_{i}} + c^{z} + {\sum\limits_{j = 1}^{N}{a_{j}^{z}\left( {{\Psi_{j}\left( {n\; } \right)} - {\lambda \; \delta_{ij}}} \right)}}}}{{\sum\limits_{j = 1}^{N}a_{j}^{m}} = 0},{{\sum\limits_{j = 1}^{N}{a_{j}^{m}{nX}_{j}}} = 0},{{\sum\limits_{j = 1}^{N}{a_{j}^{m}{nY}_{j}}} = 0},{{\sum\limits_{j = 1}^{N}{a_{j}^{m}{nZ}_{j}}} = 0},{m = x},y,z} & (5)\end{matrix}$

where δ_(ij) are the Kronecker symbols defined by the followingequations:

δ_(ij)=1 i=j

δ_(ij)=0 i≠j

The equation set (4) is a set of 3N+12 equations that includes 3N+12unknowns. Equations (4) and (5) can be solved (e.g., by registrationlogic 34) to find the 3N+12 unknown coefficients for equation set (1),whose values may be stored as coefficients 40. To solve equations (4)and (5), the collected fiducial pairs are used. Note that the equationset (4) needs data to solve for the unknown coefficients:(gX_(i),gY_(i),gZ_(i)) and n

=(nX_(i),nY_(i),nZ_(i)). The fiducial pairs provide this data: recallthat each fiducial pair has components (nX_(i),nY_(i),nZ_(i)) and(gX_(i),gY_(i),gZ_(i)), where the subscript index i=1, . . . , N is theindex numbering the fiducial pairs and N is the total number ofnon-discarded fiducial pairs collected in sub-step 204. Thus, atsub-step 206, the fiducial pair g-coordinates are used on the left-handside of equations (4). The fiducial pair n-coordinates are usedthroughout the right-hand side of equations (4), including in thesummation term, as well as for equations (5). The art is replete forapproaches (e.g., software-based) to solve a number of equations withthe same number of unknowns, and accordingly, conventional approachesmay be used to determine the respective values for the unknowncoefficients.

As described above, the collected fiducial pairs are used to solve forthe unknown coefficients in equations (4) so that those coefficients maybe applied in equations (1)—that is the first purpose of the fiducialpairs. The fiducial pairs—or, more accurately, the electricalimpedance-based coordinates in the fiducial pairs—also have a distinctsecond purpose: continuous use in real-time application of equations(1), as will be described below. Accordingly, the n-coordinates in thefiducial pairs (i.e., the coordinates measured in sub-step 204 byelectrical impedance-based MPS 12) are stored in reference coordinatesdata structure 38 for use in the summation portion of equations (1) inreal-time operation.

Equation set (1), now defined by virtue of known values for coefficients40 and further by virtue of a populated set of reference coordinates 38(e.g., the n-coordinates taken from the fiducial pairs), represent theoutput of sub-step 206 (and of step 202), namely, the interpolationfunction g(nX,nY,nZ).

After the interpolation function is determined, it may be applied (e.g.,by interpolation logic 36) during real-time device usage (e.g.,navigation, data collection, etc.) according to steps 208, 210. Step 208involves obtaining a real-time coordinate in coordinate system 14 withMPS 12 (shown as (nX,nY,nZ) in equation set (1)). The real-timecoordinate may be motion compensated by MPS 12. Step 210 involvesdetermining a corresponding real-time coordinate in coordinate system 18((gX,gY,gZ)) in accordance with the interpolation function (e.g., byinterpolation logic 36). If the interpolation function is a result ofthe thin-plate spline algorithm discussed herein, applying theinterpolation function requires a plurality of reference coordinates incoordinate system 14, such as reference coordinates 38, as input for thebasis functions in the summation term in equations (1). As can be seenfrom the summation term of equations (1), the interpolation function ineach dimension requires the same number of reference coordinates, N, aswere used by the algorithm to establish the function (i.e., solve forthe coefficients). Accordingly, step 210 may involve the recall of anN-sized set of reference coordinates 38 to apply the interpolationfunction. As noted above, the reference coordinates may be then-coordinates (i.e., the electrical impedance-based coordinates from thefiducial pairs) collected in sub-step 204. Each of the N referencecoordinates (i.e., each non-discarded electrical impedance-basedcoordinate collected in sub-step 204) is used by the summation term ofequations (1), in each dimension, to relate each new real-timen-coordinate into g-space.

Steps 208, 210 may be continuously repeated with respect to positiondata from multiple electrical impedance-based sensors on multiplemedical devices from MPS 12. By repeating steps 208, 210, MPS 12 may beoperated in coordinate system 18 substantially in real time.

The steps of method 200 may be temporally distributed among differentphases of a medical procedure. Step 202 (including sub-steps 204, 206)may be performed during a preliminary, registration phase. Steps 208,210 may be performed during a subsequent treatment or other phase, forexample. In other words, sub-steps 204, 206 may be considerednon-real-time relative to the treatment or other procedure, while steps208, 210 may be performed substantially in real-time during thetreatment or other procedure.

Operating a positioning system according to method 200 presents manyadvantages. As stated in the Background, the coordinate system of anelectrical impedance-based MPS may be inhomogenous, anisotropic, and notorthonormal. These characteristics can result in distorted geometries,for example. However, an electrical impedance-based MPS generallyprovides the ability to track a relatively large number of sensors onseveral devices at the same time. In contrast, while the coordinatesystem of a magnetic field-based MPS is generally orthonormal andhomogenous, such a magnetic-field based MPS may be limited to tracking arelatively smaller number of sensors. By enabling registration of thecoordinate system of an electrical impedance-based MPS in the coordinatesystem of a magnetic field-based MPS, method 200 provides the advantagesof both types of positioning system while minimizing the drawbacks—arelatively large number of sensors can be tracked on multiple devices inan orthonormal, homogenous coordinate system.

It should be understood that an electronic controller or ECU asdescribed above for certain embodiments may include conventionalprocessing apparatus known in the art, capable of executingpre-programmed instructions stored in an associated memory, allperforming in accordance with the functionality described herein. To theextent that the methods described herein are embodied in software, theresulting software may be stored in an associated memory and where sodescribed, may also constitute the means for performing such methods.Implementation of certain embodiments of the invention, where done so insoftware, would require no more than routine application of programmingskills by one of ordinary skill in the art, in view of the foregoingenabling description. Such an electronic controller or ECU may furtherbe of the type having both ROM, RAM, a combination of non-volatile andvolatile (modifiable) memory so that the software can be stored and yetallow storage and processing of dynamically produced data and/orsignals.

The systems and methods described herein may be tested to ensure theaccuracy of the registration process and of the resulting interpolationfunction. For example, a medical device having multiple sensors (e.g.,electrodes) with a known physical relationship with each other (i.e.,known distances between sensors) can be coupled to an MPS having anon-orthonormal coordinate system. Distances between sensors can beobtained from, e.g., the medical device product catalog. Positionreadings from the multiple sensors can be input to the interpolationfunction, and the distances between respective orthonormal coordinatesystem outputs can be compared to the known distances between electrodes(e.g., by logic executed by ECU 28). Additionally or alternatively, amedical device having similar sensor characteristics as the device usedto collect the fiducial pairs (i.e., a second dual system medicaldevice) may be swept through the mapped space to ensure that the sameresults are obtained.

The coordinate system registration and resulting interpolation functiondescribed herein may be updated during a medical procedure to ensurecontinued accuracy of the interpolation function. For example, anelectrical impedance-based coordinate system may drift during a medicalprocedure due to changes in the biological impedance of the patient.Such a biological impedance change may result from, e.g., changes incell chemistry due to saline or other hydration drips, dehydration, orchanges in body temperature. To counteract impedance drift, steps 202(including sub-steps 204, 206) may be repeated—i.e., a new set offiducial pairs may be collected and the interpolation function may bere-determined—to update the registration between the electricalimpedance-based coordinate system and the magnetic field-basedcoordinate system.

Although numerous embodiments of this invention have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this invention. All directionalreferences (e.g., plus, minus, upper, lower, upward, downward, left,right, leftward, rightward, top, bottom, above, below, vertical,horizontal, clockwise, and counterclockwise) are only used foridentification purposes to aid the reader's understanding of the presentinvention, and do not create limitations, particularly as to theposition, orientation, or use of the invention. Joinder references(e.g., attached, coupled, connected, and the like) are to be construedbroadly and can include intermediate members between a connection ofelements and relative movement between elements. As such, joinderreferences do not necessarily infer that two elements are directlyconnected and in fixed relation to each other. It is intended that allmatter contained in the above description or shown in the accompanyingdrawings shall be interpreted as illustrative only and not limiting.Changes in detail or structure can be made without departing from thespirit of the invention as defined in the appended claims.

What is claimed is:
 1. A system for determining the position of amedical device, comprising: an electronic control unit (ECU); amagnetic-based positioning system for tracking a magnetic sensor coupledto the medical device; an electrical-based positioning system fortracking an electrode coupled to the medical device; a computer-readablememory coupled to said ECU; and logic stored in said memory configuredto be executed by said ECU, said logic configured to establish, by saidECU, an interpolation function and apply said interpolation function toa first coordinate in a region of interest in a first non-orthonormalcoordinate system of the electrical-based positioning system todetermine a corresponding second coordinate in a second orthonormalcoordinate system of the magnetic-based-positioning system; wherein saidlogic is configured to determine, by said ECU, said interpolationfunction by applying, by said ECU, an interpolation algorithm to aplurality of fiducial pairs distributed throughout the region ofinterest to yield said interpolation function, each fiducial pairincluding (1) a first coordinate in said first coordinate systemmeasured by the electrical-based positioning system using data from theelectrode and (2) a second coordinate in said second coordinate systemmeasured by the magnetic-based positioning system using data from themagnetic sensor, each fiducial pair corresponding to a physical point inthree-dimensional (3D) space in the region of interest, wherein theinterpolation function determines one or more coefficients for modifyingcoordinates of said plurality of fiducial pairs.
 2. The system of claim1, wherein said logic is further configured to determine saidinterpolation function by using a smoothing parameter, wherein saidsmoothing parameter corresponds to an amount by which the secondcoordinate determined in accordance with said interpolation functioncorresponding to an obtained first coordinate can differ from a measuredsecond coordinate in a fiducial pair with a measured first coordinatethat is equivalent to the obtained first coordinate.
 3. The system ofclaim 2, wherein said logic is configured to apply said smoothingparameter to fiducial pairs comprising (1) said first coordinate in saidfirst coordinate system, compensated for patient body movement by saidfirst positioning system, and (2) said second coordinate in said secondcoordinate system, compensated for patient body movement by said secondpositioning system.
 4. The system of claim 1, wherein said logic isfurther configured to store reference coordinates in said memorycomprising each first coordinate of said plurality of fiducial pairs foruse in said interpolation function.
 5. The system of claim 1, furthercomprising a medical device comprising a first sensor configured tooutput a first signal indicative of a first position in said firstnon-orthonormal coordinate system and a second sensor configured tooutput a second signal indicative of a second position in said secondorthonormal coordinate system.
 6. The system of claim 5, wherein saidfirst sensor and said second sensor are fixed on said medical device ata known physical relationship to each other.
 7. The system of claim 5,wherein said medical device is a first medical device and said logic isconfigured to establish said interpolation function by applying athin-plate spline algorithm to a plurality of fiducial pairs collectedwith said first medical device, said system further comprising: a secondmedical device comprising a first sensor configured to output a firstsignal indicative of a first position in said first non-orthonormalcoordinate system and a second sensor configured to output a secondsignal indicative of a second position in said second orthonormalcoordinate system; wherein said logic is configured to test saidinterpolation function according to said first and second signals fromsaid second medical device.
 8. The system of claim 1, further comprisingsaid first positioning system associated with said first non-orthonormalcoordinate system.
 9. The system of claim 1, further comprising saidsecond positioning system associated with said second orthonormalcoordinate system.
 10. The system of claim 1, wherein said logic isfurther configured to display a location of the medical device based onthe second coordinate for each of the plurality of fiducial pairs.